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Pyridostigmine and Amifampridine for Myasthenia Gravis

NCT05919407 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-06-26

No results posted yet for this study

Summary

A randomized, double-blind, placebo controlled, crossover intervention study evaluating the effect of pyridostigmine (part 1) and amifampridine (part 2) in Myasthenia Gravis (MG).

Conditions

Interventions

DRUG

Pyridostigmine

Participants will receive pyridostigmine 10 mg tablets.

DRUG

Amifampridine (base) with modified release

Participants will receive amifampridine (base) with modified release 15 mg or 30 mg tablets.

DRUG

Placebo

The placebo tablets will be identical apart from the active substance (pyridostigmine)

DRUG

Placebo

The placebo tablets will be identical apart from the active substance (amifampridine base)

Sponsors & Collaborators

  • NMD Pharma A/S

    collaborator INDUSTRY

  • Leiden University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2024-09-22
Completion
2024-09-22

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05919407 on ClinicalTrials.gov